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Effekt av CIBINQO med topikal behandling

JADE COMPARE var en randomisert, dobbeltblind, dobbeltdummy, placebokontrollert pivotal fase 3 klinisk studie som evaluerte effekt og sikkerhet av CIBINQO i kombinasjon med TCS vs placebo + TCS hos 837 voksne pasienter med moderat til alvorlig AD, med en direkte head-to-head sammenligning vs dupilumab for kløelindring, målt ved PP-NRS4, ved uke 2.2

Hudforbedring

Kløelindrende effekt

Pasientrapporterte utfall (PROs)

Se studiedesign >

Rask og signifikant hudforbedring vist med CIBINQO + TCS2

Data limitations
EASI-75 response for CIBINQO vs placebo at week 12 was a prespecified, multiplicity-controlled primary endpoint and at week 16 was a prespecified multiplicity-controlled key secondary endpoint. All other time points were prespecified, non–multiplicity-controlled secondary endpoints. Therefore, treatment differences could represent chance findings and no conclusions regarding other comparisons can be made. This study was not designed to evaluate CIBINQO vs dupilumab with respect to EASI-75 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

EASI-75 response is defined as at least 75% improvement in EASI score from baseline. 
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required. 
AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; EASI=Eczema Area and Severity Index; QD=once a day; Q2W=every 2 weeks.Rask og signifikant hudforbedring (IGA 0/1) ved begge doser av CIBINQO + TCS2

Data limitations
IGA 0/1 response for CIBINQO vs placebo at week 12 was a prespecified, multiplicity-controlled primary endpoint and at week 16 was a prespecified, multiplicity-controlled key secondary endpoint. All other time points were prespecified, non–multiplicity-controlled secondary endpoints. Therefore, treatment differences could represent chance findings and no conclusions regarding other comparisons can be made. This study was not designed to evaluate CIBINQO vs dupilumab with respect to IGA 0/1 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
IGA=Investigator’s Global Assessment.En andel av pasientene oppnådde EASI-90, en høyere terskel for hudforbedring, med begge doser av CIBINQO + TCS3,5

Data limitations
EASI-90 response was a prespecified secondary endpoint not controlled for multiplicity. Therefore, treatment differences could represent chance findings and no conclusions regarding any comparisons can be made. The study was not designed to evaluate CIBINQO vs dupilumab with respect to EASI-90 response. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

EASI-90 response is defined as at least 90% improvement in EASI score from baseline.
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.2JADE COMPARE Studiedesign Tilpasset av Pfizer2-4

Coprimary endpoints:

  • EASI-75 response at week 12 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 vs placebo
Key secondary endpoints:
  • PP-NRS4 response at week 2 vs dupilumab and vs placebo
  • EASI-75 response at week 16 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 16 vs placebo
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS. TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.Patients randomised to dupilumab received a loading dose of 600 mg.At week 16, patients taking placebo were randomised to CIBINQO 200 mg + TCS or CIBINQO 100 mg + TCS.
Dupilumab or its matching placebo was administered for 16 weeks, with the final injection planned for week 14 to facilitate the washout of dupilumab prior to eligible subjects entering the long-term extension study.
At week 20, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week off-treatment follow-up period.SC=subcutaneous. Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoadingRask og signifikant kløelindrende effekt for pasienter1-4 Se resultaterLoadingReferences:CIBINQO SPCBieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Supplementary appendix to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Ständer S, Kwatra SG, Silverberg JI, et al.Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial; Am J Clin Dermatol. 2023 Jan;24(1):97-107. doi: 10.1007/s40257-022-00738-4.

See full trial design >

Rask og signifikant kløelindrende effet vs dupilumab 300 mg + TCS ved uke 2 med CIBINQO 200 mg + TCS2

Data limitations4,5
PP-NRS4 response for CIBINQO vs dupilumab and vs placebo at week 2 was a prespecified key secondary endpoint controlled for multiplicity. The onset of pruritus relief was assessed through a step-down approach, day by day, from week 2 to earlier time points once statistical significance was demonstrated at week 2, at the 5% level of significance. Any hypotheses made after the last day for which the comparison was significant was not considered statistically significant. P values at day 4 and day 9 are controlled for multiplicity for the family of PP-NRS4 comparisons. 

PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS. 
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.CIBINQO was compared to dupilumab in a key secondary head-to-head endpoint at week 2. This endpoint was further analysed as a prespecified, multiplicity-controlled analysis and CIBINQO 200 mg + TCS showed superiority vs dupilumab down to day 4. The difference in PP-NRS4 between CIBINQO 100 mg + TCS and dupilumab + TCS was not statistically significant at week 2.
AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day; Q2W=every 2 weeks.JADE COMPARE Studiedesign Tilpasset av Pfizer2-4

Coprimary endpoints:

  • EASI-75 response at week 12 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 vs placebo

Key secondary endpoints:

  • PP-NRS4 response at week 2 vs dupilumab and vs placebo
  • EASI-75 response at week 16 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 16 vs placebo
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS. TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.Patients randomised to dupilumab received a loading dose of 600 mg.At week 16, patients taking placebo were randomised to CIBINQO 200 mg + TCS or CIBINQO 100 mg + TCS.
Dupilumab or its matching placebo was administered for 16 weeks, with the final injection planned for week 14 to facilitate the washout of dupilumab prior to eligible subjects entering the long-term extension study.
At week 20, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week off-treatment follow-up period.
SC=subcutaneous; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment.Finn ut mer Har du spørsmål om effekt? Be om en eRep-samtaleLoading Forbedring av livskvalitet (DLQI) ved CIBINQO + topikal behandling4,6 Se resultaterLoadingReferences:CIBINQO SPCBieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Ständer S, Kwatra SG, Silverberg JI, et al.Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial; Am J Clin Dermatol. 2023 Jan;24(1):97-107. doi: 10.1007/s40257-022-00738-4. Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Supplementary appendix to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Thyssen JP, Yosipovitch G, Paul C, et al. Supplementary appendix to: Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis [published online ahead of print, 2021 Nov 15]. J Eur Acad Dermatol Venereol. 2021;10.1111/jdv.17813. doi:10.1111/jdv.17813

Se studiedesign >

I post hoc analyse, 

Pasienter rapporterte forbedring i alvorlighetsgraden av AD-symptomer innen uke 12 med
CIBINQO + TCS vs placebo + TCS²

POEM er et pasientrapportert utfallsmål som brukes til å evaluere alvorlighetsgraden av AD ved å måle hyppigheten av symptomer over en ukes varighet, inkludert kløe, søvnforstyrrelser, blødende hud, væskende hud, sprukket hud, flassende hud og tørr/grov hud, fra pasientens perspektiv.3 

Ved baseline var gjennomsnittsverdien for POEM totalskår 21,1 for alle grupper, som representerer alvorlige AD-symptomer. Grafen ovenfor representerer prosentandel av pasienter som oppnådde ingen eller nesten ingen AD-symptomer.1,4

Data limitations
POEM total score 0-2 (clear/almost-clear response) was a post hoc analysis and the P values are nominal. The study was not designed to evaluate CIBINQO vs dupilumab with respect to POEM. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

POEM is the copyright of the University of Nottingham.
TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
A POEM score of 0-2 is defined as clear or almost-clear AD symptoms.4,5Analysis included the subset of patients with ≥3 points in POEM at baseline.AD=atopic dermatitis; PP-NRS=Peak Pruritus Numerical Rating Scale; QD=once a day; Q2W=every 2 weeks.

I post hoc analyse,

~9/10 pasienter rapporterte en klinisk relevant forbedring i QoL med CIBINQO 200 mg + TCS ved uke 122,6

DLQI er designet for å måle helserelatert livskvalitet hos pasienter med dermatologiske tilstander. En forbedring av ≥4-punkts reduksjon i DLQI-score anses som klinisk relevant.1,6

Data limitations
DLQI improvement ≥4 points was a post hoc analysis and the P values are nominal.
The study was not designed to evaluate CIBINQO vs dupilumab with respect to DLQI. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
QoL=quality of life.

I post hoc analyse,

Pasienter rapporterte rask forbedring i søvnmangel relatert til AD med CIBINQO + TCS ved uke 122,7

SCORAD er et klinisk verktøy som brukes til å vurdere omfanget og alvorlighetsgraden av AD. Dette verktøyet tar hensyn til kroppsområde, AD-intensitet og subjektive symptomer, som kløe og søvn, de siste 3 nettene. SCORAD VAS søvnmangel er et domene i den sammensatte SCORAD.1,8

Data limitations
SCORAD VAS sleep loss <2 response was a post hoc analysis and the P values are nominal. 
The study was not designed to evaluate CIBINQO vs dupilumab with respect to SCORAD VAS sleep loss subscale. Therefore, results are not to be interpreted as evidence of superiority, non-inferiority, or similarity between CIBINQO and dupilumab.

TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.1 A SCORAD sleep loss score of <2 is defined as minimal or no sleep loss.7VAS=visual analog scale.JADE COMPARE Studiedesign Tilpasset av Pfizer2-4

Coprimary endpoints:

  • EASI-75 response at week 12 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 12 vs placebo
Key secondary endpoints:
  • PP-NRS4 response at week 2 vs dupilumab and vs placebo
  • EASI-75 response at week 16 vs placebo
  • IGA response defined as a score of 0 or 1, with an improvement of ≥2 points from baseline at week 16 vs placebo
EASI-75 response is defined as at least 75% improvement in EASI score from baseline.PP-NRS4 is defined as an improvement of ≥4 points from baseline in the severity of PP-NRS.TCS includes low- to medium-potency topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase-4 inhibitors, per protocol guidance in JADE COMPARE. Nonmedicated topicals were also required.
Patients randomised to dupilumab received a loading dose of 600 mg.At week 16, patients taking placebo were randomised to CIBINQO 200 mg + TCS or CIBINQO 100 mg + TCS.
Dupilumab or its matching placebo was administered for 16 weeks, with the final injection planned for week 14 to facilitate the washout of dupilumab prior to eligible subjects entering the long-term extension study.
At week 20, eligible subjects had the option to enter JADE EXTEND, the long-term extension study; all other subjects entered the 4-week off-treatment follow-up period.
SC=subcutaneous; EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment.Finn ut mer Har du et spørsmål om effekt? Be om en eRep-samtaleLoading Hudforbedring ved CIBINQO som monoterapi11,12 Se resultaterLoadingReferences:Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Thyssen JP, Yosipovitch G, Paul C, et al. Supplementary appendix to: Patient-reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate-to-severe atopic dermatitis [published online ahead of print, 2021 Nov 15]. J Eur Acad Dermatol Venereol. 2021;10.1111/jdv.17813. doi:10.1111/jdv.17813Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients’ perspective. Arch Dermatol. 2004;140(12):1513-1519.Charman CR, Venn AJ, Ravenscroft JC, Williams HC. Translating Patient-Oriented Eczema Measure (POEM) scores into clinical practice by suggesting severity strata derived using anchor-based methods. Br J Dermatol. 2013;169(6):1326-1332.The University of Nottingham. POEM – Patient-oriented eczema measure. Accessed 9 March 2023. https://www.nottingham.ac.uk/research/groups/cebd/documents/methodological-resources/poem-for-self-completion-or-proxy-completion.pdfBasra MKA, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.Simpson EL, Bieber T, Eckert L, et al. Patient burden of moderate to severe atopic dermatitis (AD): insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016;74(3):491-498.European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Dermatology. 1993;186(1):23-31.Bieber T, Simpson EL, Silverberg JI, et al; for the JADE COMPARE Investigators. Supplementary appendix to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Bieber T, Simpson EL, Silverberg JI, et al. Supplementary protocol to: Abrocitinib versus placebo or dupilumab for atopic dermatitis. N Engl J Med. 2021;384(12):1101-1112.Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266.Silverberg JI, Simpson EL, Thyssen JP, et al. Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(8):863-873.CIBINQO SPC
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